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Updated: May 23, 2025

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A Perspective on the Appropriate Implementation of ICH E9(R1) Addendum Strategies for Handling Intercurrent Events.

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Summary

This study highlights the limitations of current clinical trial strategies for handling intercurrent events. It advocates for treatment policy estimands in standard-of-care control arms to ensure scientifically rigorous causal inference and real-world relevance.

Keywords:
causal inferenceestimandsintercurrent eventsrandomization

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Area of Science:

  • Clinical Trials Methodology
  • Biostatistics
  • Pharmaceutical Research

Background:

  • Intercurrent events in randomized clinical trials (RCTs) complicate result interpretation.
  • The ICH E9(R1) Addendum on estimands has prompted discussions on trial objectives.
  • Current strategies like 'while on treatment' or 'hypothetical' have limitations in preserving randomization integrity and capturing net effects.

Purpose of the Study:

  • To describe the advantages of using treatment policy estimands with standard-of-care control arms in RCTs.
  • To address limitations of existing methods for handling intercurrent events.
  • To improve the design, conduct, and analysis of clinical trials for reliable causal inference.

Main Methods:

  • Proposing "treatment policy" approaches for estimands to manage intercurrent events.
  • Suggesting composite endpoints that incorporate events like death.
  • Advocating for standard-of-care control arms in trial design.

Main Results:

  • Treatment policy estimands protect randomization integrity, enabling scientifically rigorous causal inference.
  • These estimands provide meaningful, unconditional information relevant to real-world settings.
  • The proposed strategies reliably evaluate interventions within a complete treatment regimen.

Conclusions:

  • Standard-of-care control arms with treatment policy estimands offer superior scientific rigor and real-world applicability.
  • Improved trial design and analysis are crucial for addressing clinically important questions reliably.
  • This approach enhances the ability to make informed decisions about adopting new interventions.